CA2751087A1 - Device for protecting an area of the human body, in particular for preventing eschars - Google Patents

Abstract

The invention relates to a device for protecting the skin of the human body, including a pad (1) made of a polymer gel comprising an outer protection layer (4), and a surface (21, 31) opposite the outer layer, to be applied on an area of skin to be protected, the pad (1) including a protection portion (2) and at least one adhesive portion (3a, 3b) to be brought into contact with the skin, the protection portion being adapted so as to ensure a mechanical protection of the area to be protected, and the adhesive portion having an adhesion power greater than that of the protection layer in order to maintain said pad on the area to be protected.

Description

AJR 03!; 20 :: / ~ IEP. 15:49 CABINET OMNIPAT N FAX: 33 0442990359 F. CIE

DEVICE FOR PROTECTING A DJ AREA HUMAN BODY
NOTABLY FOR THE PREVENTION OF THE ESCARRES

The present invention relates to the protection of a particular area of the skin in order to prevent the pressure ulcer formation. More generally, this The invention aims to provide mechanical protection and hydration of a relatively large area of the skin, and especially an area where the skin is weakened for example by pathologies such as psoriasis or eczema, or by a recent scar.
It is known to use platelets based on polymeric gel such as silicone gel or based hydrogel to provide a protective function of the skin or load distribution. But the constraints related to the effect of the wafer on the skin often conflict with the constraints related to the maintenance of the plate s-, zr the area to be protected handling, transport and storage of p_aquette.
For example to ensure a function of load distribution, it is known to use a platelet in a PDMS type silicone gel (polydimethylsiloxane) relatively hard. Platelets in silicone gel harder but more adhesive are for example described in documents FR 2 712 497 and FR 2 904 932. However, silicone gels of this type are very little adhesive, and in any case, insufficiently adhesive to hold in place naturally on the area to be protected. In addition, to ensure load distribution, the plate must have a certain thickness of several millimeters, which opposes the maintenance of the plate on the area to be protected. Indeed, the more edges of wafer are thick plus they may be hooked, ation: 06.04.2011 15:51:38 - 06.04.2011 15:54:43. This page 15 of 24 was completed at 06.04.2011 15:53:37 teceived at the EPO on Apr 06, 2011 15:54:43. Page 15 of 24 MODIFIED SHEET

06 / AVR / 2011iMER 15:49 OMNIPAT CABINET N 'FAX: 33 0442990669 P. OIE

2 causing tearing of the wafer.
For example, there are known US 4,655,767 and WO 00/5

3 139 to dissociate the function of treatment or protection of the function of maintenance on the skin, in using an adhesive tape on which is disposed the element providing the processing function o-.u protection. However, this solution does not happen particularly when the surface to be protected is relatively large, and when the skin to be protected is brittle. In fact, people at risk pressure ulcers often have fragile, poorly vascularized skin and sometimes dry. conventional film adhesives polyurethane may cause maltreatment of the skin (tearing of pieces of skin or hair) during 1j removal of the film. This naltraitance is all the more important and penal'-skips that the adhesive surface is large.
It is also essential_ to avoid any risk of allergy, which is common with classical solutions.
It is therefore desirable to make a device protection able to protect a relatively large skin surface, without risk of allergy, and which is likely to stick to the skin without risk of inadvertent detachment and without risk of mistreatment of the skin when removing the device.
Embodiments may relate to a protective device of an area of the body skin human, comprising a wafer having a face covered with an outer layer, and a face opposite to the outer layer, intended to be applied to an area of the skin to protect. According to one embodiment, the wafer includes a protective portion of a gel polymer and at least one adhesive part in a gel polymer, intended to come into contact with the skin, protective portion being configured to provide a mechanical protection of the area to be protected, polymer gel ition: 06.04.2011 15:51:38 - 06.04.2011 15:54:43. This page 16 of 24 was completed at 06.04.2011 15:53:45 ; eeived the EPO on Apr 06, 2011 15:54:43. Page 16 of 24 MODIFIED SHEET

03 / AVR / M11 / 0,3 15:49 CABINET OMNIPAT N FAX: 33 0442990669 P. 017 forming the adhesive portion having adhesive power greater than that forming the protective part for ensure the maintenance of the plate on the zone to be protect.
According to one embodiment, the protective part of the wafer has a thickness between 1 and 4 mm.
According to one embodiment, the adhesive part has a thickness of between 0.2 and 0.5 mm.
According to one embodiment, the protective part is carried out by at least partial polymerization of a mixture comprising: about 15% of polydimethylsiloxane with dimethyl-vinyl terminations having a viscosity above 20000 Ia? as, about 25% of polydimethylsiloxane with dimethyl-vinyl terminations having a viscosity of between 200 and 20000 mPa.s, about 45% polydimethylsiloxane with terminations triethyl having a viscosity of less than 100 nPA.s, about 12% of pyrogenation silica treated trimethylsiloxy, and about 3% of Polydimethylsiloxane-polymethylhydrogensiloxane Terminals dimethyl-hydrogen.
According to one embodiment, the protective part is carried out by at least partial polymerization of a mixture comprising about 15% polydimethylsiloxane with dimethyl vinyl endings having a viscosity greater than 20000 mPa.s, approximately 25% of polydimethylsiloxane with dimethyl-vinyl terminations having a viscosity of between 200 and 2000G mPa.s, about 25% polydimethylsiloxane with terminations trimethyls having a viscosity of less than 100 mPa.s, about 20% polydimethylsiloxane endings trimethyls having a viscosity greater than 20000 mPa.s, about 12% fumed silica treated trimethylsiloxy, and about 3% of tion: 06.04.2011 15:51:38 - 06.04.2011 15:54:43. This page 17 of 24 was completed at 06.04.2011 15:53:54 eceived at the EPO on Apr 06, 2011 15:54:43. Page 17 of 24 MODIFIED SHEET

06 / APR / 2011 / SEP 15:50 OMNIPAT CABINET N FAX: 33 0442990669 P.018

4 Polydimethylsiloxane-polymethylhydrogensiloxane dimethyl-hydrogen endings.
According to one embodiment, the adhesive part is made of Epithelium 26.
According to one embodiment, the outer layer is in fabric "and is glued to one side of the part protective and adhesive part.
According to one embodiment, the fabric forming the outer layer is elastic.
According to one embodiment, which layer external is in a thick non-adhesive silicone gel 0.2 to 0.4 mm or silicone adhesive of thickness between 0.05 and 0.4 mm.
According to one embodiment, each part adhesive has a width of between 5 and 60 mm and an adhesive power of the order of 130 to 140 g / cm 2.
Embodiments may relate to also a method of manufacturing a device for protection of an area of the skin of the human body. according to an embodiment, the method comprises steps of forming a wafer comprising a portion protective in a polymer gel and at least a part adhesive in a polymer gel, intended to come into contact with the skin, the protective part being configured to provide mechanical protection for the area to be protected, the polymer gel forming the adhesive part having a adhesive strength greater than that forming the part protective device to ensure the maintenance of the plate on the area to be protected.
According to one embodiment, the method comprises steps of forming the adhesive part from of a first liquid mixture deposited on a support, and formation of the protective part from a second liquid mixture deposited on the support, the first mixture and the second mixture partially blending in a tion: 06.04.2011 15:51:38 - 06.04.2011 15:54:43. This page 18 of 24 was completed at 06.04.2011 15:54:02 eceived at the EPO on Apr 06, 2011 15:54:43. Page 18 of 24 MODIFIED SHEET

06 / APR / 2011 / WED 15:50 OMNIPAT CABINET N FAX: 33 0442990669 P.019 4a interface area, before complete polymerization of the two mixtures.

ition: 06.04.2011 15:51:38 -06.04.201115: 54: 43. This page 19 of 24 was completed at 06.04.2011 15:54:05 , on the EPO on Apr 06, 2011 15:54:43. Page 19 of 24 MODIFIED SHEET

According to one embodiment, the second mixture comprises: about 15% of polydimethylsiloxane dimethyl-vinyl terminations having a viscosity greater than 20000 mPa.s, approximately 25% of

5 polydimethylsiloxane with dimethyl-vinyl terminations having a viscosity of between 200 and 20000 mPa.s, about 45% polydimethylsiloxane with terminations trimethyls having a viscosity of less than 100 mPa.s, about 12% treated pyrogenation silica trimethylsiloxy, and about 3% of Polydimethylsiloxane-polymethylhydrogensiloxane dimethyl-hydrogen endings.
According to one embodiment, the second mixture comprises: about 15% of polydimethylsiloxane dimethyl-vinyl terminations having a viscosity greater than 20000 mPa.s, approximately 25% of polydimethylsiloxane with dimethyl-vinyl terminations having a viscosity of between 200 and 20000 mPa.s, about 25% polydimethylsiloxane with terminations trimethyls having a viscosity of less than 100 mPa.s, about 20% polydimethylsiloxane endings trimethyls having a viscosity greater than 20000 mPa.s, about 12% fumed silica treated trimethylsiloxy, and about 3% of Polydimethylsiloxane-polymethylhydrogensiloxane dimethyl-hydrogen endings.
According to one embodiment, the two mixtures liquids are deposited on a medium scrolling so to form bands, the first mixture being deposited on the support so as to form two adhesive strips between which the second mixture is deposited to form the protective part in the form of tape.
According to one embodiment, the thickness and the width of each of the protective and adhesive parts are adjusted by a squeegee and lateral guides.

6 According to one embodiment, the method comprises a fixing step on one side of the plate opposite to the face intended to come into contact with the skin of a non-adhesive outer layer.
According to one embodiment, the outer layer is in a fabric stuck on the plate.
According to one embodiment, the outer layer is in a non-adhesive polymer gel of thickness between 0.2 and 0.4 mm or a thick silicone glue between 0.05 and 0.4 mm.
According to one embodiment, the face of the wafer intended to come into contact with the skin is covered with a protective film.

Exemplary embodiments of the invention will be described in the following, by way of non-limiting relation to the attached figures among which:
FIG. 1 schematically represents a device for protection according to one embodiment, FIG. 2 schematically represents a profile view a machine for manufacturing the protection device, according to one embodiment, FIG. 3 is a schematic view from above of the manufacturing machine shown in Figure 2, FIG. 4 schematically represents a device for protection according to another embodiment, FIG. 5 schematically represents the device for protection of FIG. 4 in a configuration ready to employment.
FIG. 1 represents a protection device according to one embodiment. In Figure 1, the protection device is in the form of a plate 1 comprising a central portion 2 provided for cover an area to be protected from the skin of the human body, and side portions 3a, 3b having a face

7 rear 32 and an adhesive front face 31 intended to come in contact with the skin and to maintain the plate 1 on the area to be protected. Central part 2 presents a front face 21 provided to come into contact with the skin, a rear face 22 and a thickness adapted to mechanical protection properties sought.
The thickness of the lateral parts 3a, 3b may be more small than that of the central part 2. The parties side are integral with the central part of so that the front face 21 of the central part is located substantially in the same plane as the face before 31 of the side parts. The rear faces 22 and 32 of the central part and the lateral parts are covered with a protective layer 4.
The lateral parts 3a, 3b can be realized in a crosslinked silicone gel to be sufficiently adhesive, for example Epithelium 28 marketed by the Millet Innovation company. This material is characterized by a very high adhesiveness, without risk of provoking tearing of skin or hair when removing the protection device, and does not risk provoking allergies. The thickness of the lateral parts 3a, 3b can be relatively small, for example between 0.2 and 0.5 mm.
The central part 2 can be made of a gel polymer, for example a silicone gel. If the part Central Unit 2 must provide mechanical protection, is made of a crosslinked silicone gel to be relatively hard and therefore weakly adhesive. The part center 2 has a thickness which can be a ten times larger than that of the parties lateral 3a, 3b.
In an application to prevention against pressure ulcers, the central part 2 is made of a gel of silicone, having a thickness of between 1 to WO 2010/09242

8 PCT / IB2009 / 007628 4 mm thick, and stiffness properties, viscosity and damping factor able to limit the underlying shears and maintain a microcirculation in the protected tissues, despite the presence of pressure. For this purpose, the silicone gel may present at 35 C a rigidity or component elastic range from about 11000 to 20000 Pa, a viscosity or damping component varying from 700 to 8000 Pa and a damping factor varying from about 0.06 to 0.38, when a shear rate varies between 0 and 100 rd / s.
These properties are for example obtained when the central portion 2 is made by polymerizing at least partially one or the other of two mixtures whose composition is summarized in Table 1 below Table 1 Component Mixture 1 Mixture 2 terminated polydimethylsiloxane about dimethyl vinyls of viscosity 15% 15%
greater than 20000 mPa.s terminated polydimethylsiloxane about dimethyl vinyls of viscosity between 25% 25%
200 and 20000 mPa.s Polydimethylsiloxane with terminations about trimethyls of lower viscosity than 45% 25%
100 mPa.s terminated polydimethylsiloxane about trimethyls of high viscosity 0 20%
greater than 20000 mPa.s pyrogenic silica treated about trimethylsiloxy 12% 12%
co-polydimethylsiloxane-polymethyl about hydrogen siloxane with terminations 3% 3%
dimethyl-hydrogen

9 Partial polymerization of mixtures 1 and 2 can be obtained using a catalytic system to platinum base complexed vinylesiloxanes. When she is made from mixtures 1 and 2, the central part 2 has an adhesiveness between 100 to 115 g / cm 2.
The protective layer 4 can be made in one tissue, for example an elastic fabric, such as a fabric polyamide elastane.
A protective film 6 can be arranged on the faces 21 and 31, intended to come into contact with the skin, to allow the storage and transport of protection device 1, the protective film being removed just prior to the application of device 1 on the skin.
Figures 2 and 3 show a machine of manufacture of the protection device. The machine 20 makes it possible to manufacture platelets 1 in the form of a continuous band. The machine 20 comprises a support band

10 non-stick, for example PVC, which is unwound on one side of a coil 11 and wound on the other around of another coil 12. Between the two coils 11, 12, the band 10 moves substantially horizontally in a direction of travel indicated by the arrow 17. The machine 20 comprises at least two lateral nozzles 14a, 14b and a or several central nozzles 13 which can be installed at a distance from the side nozzles to the coil 12. The nozzles 14a, 14b make it possible to forming the side portions 3a, 3b of the wafer 1. A
this effect, the nozzles 14a, 14b deposit on the band 10 a first mixture of silicone oils between guides lateral, internal 15a and external 15b arranged longitudinally and vertically on the strip 10. The nozzle 13 makes it possible to form the central part 2 of the 1. To this end, the nozzle 13 deposits between the two internal guides 15a a second mixture of silicone. The flow rate of the nozzles 13, 14a, 14b is adapted to the crosslinking time of the blends, at the speed of scrolling of the strip 10 and to the dimensions of the parts central 2 and lateral 3a, 3b.
The manufacturing machine 20 also includes squeegees 16, 19 arranged horizontally above the band 10 to adjust the thickness of the parts lateral parts 3a, 3b and of the central part 2. The combination of guides' 15a, 15b and squeegees allows 10 to finely adjust the respective widths and thicknesses central and lateral parts 3a, 3b.
The first mixture is designed to obtain particular spreading conditions on the strip 10, a some polymerization time and properties viscoelastic and final tackiness appropriate. The second blend is designed to get properties viscoelastics corresponding to the function to be protective device to achieve. The first and second mixtures contain for example PDMS
(Polydimethylsiloxane).
At the downstream end 18 (relative to the direction of scrolling 17) of the guides 15a, 15b, the lateral parts 3a, 3b whose viscosity has become greater than that of the second mixture partly retain the central 2 less viscous. Like the central part 2 is thicker than the lateral parties 3a, 3b, the second mixture tends to overlap in an area interface of small width the lateral parts 3a, 3b. In this interface area, silicone oils not yet polymerized both mixtures tend to to mix. Thus, after polymerization, a polymerization complete continuity between the central part and the side parts. Also note that the first mixture forming the lateral parts 3a, 3b polymerizes

11 faster than the second mixture forming the part Central 2.
Downstream of the guides 15a, 15b, the polymerization of the two mixtures continues for example in a tunnel of polymerization (not shown) which can be heated to accelerate the polymerization and therefore the rate of production of the protective device. At the end of the polymerization, the whole of the wafer 1 in band and of the support strip 10 is wound on the coil 12. The bobbin 12 is then placed in a gluing machine continuously from the outer layer 4 on the faces 22 and 32 central and lateral parts, and application on the opposite faces 21 and 31 of the protective film 6.
The wafer 1 has an adhesive power sufficient when the lateral parts 3a, 3b a width between 5 and 60 mm and a power adhesive of the order of 130 to 140 g / cm 2.
Moreover, it should be noted that the first mixture can be alternately deposited on the support strip 10 after the second mixture.
Figure 4 shows a protective plate according to another embodiment. The wafer differs from the wafer 1 shown in FIG.
that the layer of fabric 4 is replaced by a layer in relatively hard and non-adhesive polymeric gel. The layer 5 can be formed in the manufacturing machine before the lateral parts 3a, 3b and central 2, the first and second mixtures being cast on the layer 5 after at least partial polymerization of this last, so as to obtain a mixture of layers in interface areas and so continuity complete between layer 5 and the central parts 2 and lateral 3a, 3b. The lateral parts 3a, 3b are thus linked to the central part 2 by zones junction 7a, 7b made of a different material.

12 The layer 5 can be made of a silicone gel, for example example of the type Epithelium 26 marketed by the Millet Innovation company, and has a thick between 0.2 and 0.5 mm. The protective layer 5 can also be made in a thin layer of glue silicone such as an adhesive marketed to achieve assemblies of silicones, the adhesiveness of which plays no or very little on the support strip 10. Layer 5 can thus have an even lower thickness and be almost transparent.
Figure 5 shows the plate in a ready-to-use configuration, or during application of the protective film 6 on the faces 21 and 31 of the parts central 2 and lateral 3a, 3b. In the configuration represented in FIG. 4, the faces 21 of the part central 2 and 31 side parts are not in the same plan because of the manufacturing method put implemented. In the configuration shown in the figure 5, the side portions 3a, 3b and the layer 5 have been deformed so that the faces 31 are at less partly in the plane of the face 21.
The band obtained by the machine 10 is used in first cutting a piece of tape to a length corresponding to that of the skin zone to protect, to obtain an individual plate 1 or the. The protective film 6 is then removed from the wafer that is then applied to the area to protect. The adhesiveness and fineness of the parts 3a, 3b of the wafer 1 or allows it a excellent maintenance of the wafer on the skin. By elsewhere, when the central part 2 is made in one silicone gel sufficiently thick and hard to ensure a good load distribution, it proves to be able to absorb a substantial part of the efforts of shear and compression that can undergo the

13 tissues in the vicinity of a bone. Central part 2 turns out also able to reduce the solicitations repeated dynamics of tissues that cause fatigue skin and deep tissue and vessels.
It can therefore also maintain the irrigation of tissue. The adhesiveness of the central part, although low, is also sufficient to limit important way the friction between the skin and its environment. The central part 2 is therefore effective to prevent the formation of bedsores. This character protector is reinforced by the fact that the gel silicone is relatively waterproof and promotes therefore the hydration of the skin in contact by exudation.
This results in improved vascularity superficial skin contact, which tends to prevent the formation of bedsores. Note that the plate 1 or the can be easily detached from the skin, without risk of lesion formation even with fragile skin. The plate 1 or the can also be cleaned easily for reuse, cleaning not affecting the adhesive nature of the parts lateral 3a, 3b.
The protection device previously described can also be used for other purposes, by example to resorb keloid scars or protect areas of the skin with psoriasis or of eczema.
It will be clear to those skilled in the art that the present invention is susceptible of various variants of realization. In particular, the invention is not limited to a protective device manufactured in cut. The protective device can be manufactured directly in the form of platelets of different dimensions, by pouring adequate quantities of liquid mixtures in individual molds with

14 mobile guides to separate the mixtures at the beginning of their polymerization.

Claims (20)

1. Device for protecting an area of the skin of the human body, comprising a wafer comprising a face (22, 32) covered with an outer layer (4, 5), and a face (21, 31) opposite to the outer layer, intended for to be applied on an area of the skin to be protected, characterized in that the wafer comprises a protective part (2) in a gel, polymer and at least one adhesive portion of a polymer gel (3a, 3b) for come in contact with the skin, the protective part being configured to provide mechanical protection of the area to be protected, the polymer gel forming the part adhesive having an adhesive strength greater than that forming the protective part to ensure the maintenance of the wafer on the area to be protected. 2. Device according to claim 1, wherein the protective part (2) of the wafer (1, 1 ') has a thickness of between 1 and 4 mm. 3. Device according to claim 1 or 2, in wherein the adhesive portion (3a, 3b) has a thickness between 0.2 and 0.5 mm. 4. Device according to one of claims 1 to 3, wherein the protective portion (2) is made by at least partial polymerization of a mixture comprising:
about 15% polydimethylsiloxane with terminations dimethyl vinyls having a viscosity exceeding 20000 mPa.s about 25% polydimethylsiloxane with terminations dimethyl vinyls having a viscosity of between 200 and 20000 mPa.s, about 45% polydimethylsiloxane with terminations trimethyls having a viscosity of less than 100 mPa.s, about 12% fumed silica treated trimethylsiloxy, and about 3% of co-polydimethylsiloxane-polymethyl-hydrogenosiloxane with dimethyl-hydrogen terminations. 5. Device according to one of claims 1 to 3, wherein the protective portion (2) is made by at least partial polymerization of a mixture comprising:
about 15% polydimethylsiloxane with terminations dimethyl vinyls having a viscosity exceeding 20000 mPa.s about 25% polydimethylsiloxane with terminations dimethyl vinyls having a viscosity of between 200 and 20000 mPa.s, about 25% polydimethylsiloxane with terminations trimethyls having a viscosity of less than 100 mPa.s, about 20% polydimethylsiloxane with terminations trimethyls having a viscosity greater than 20000 mPa.s, about 12% fumed silica treated trimethylsiloxy, and about 3% of co-polydimethylsiloxane-polymethyl-hydrogenosiloxane with dimethyl-hydrogen terminations. 6. Device according to one of claims 1 to 5, wherein the adhesive portion (3a, 3b) is made of Epithelium 28®. 7. Device according to one of claims 1 to 6, wherein the outer layer (4) is of fabric and is glued on one side of the protective part (2) and the adhesive portion (3a, 3b). 8. Device according to claim 7, wherein the fabric forming the outer layer (4) is elastic. 9. Device according to one of claims 1 to 7, wherein the outer layer (5) is in a gel of non-adhesive silicone with a thickness of between 0.2 and 0,4 mm or silicone glue included between 0.05 and 0.4 mm. 10. Device according to one of claims 1 to 8, wherein each adhesive portion (3a, 3b) has a width between 5 and 60 mm and a power adhesive of the order of 130 to 140 g / cm 2. 11. A method of manufacturing a device for protecting an area of the skin of the human body, characterized by comprising training steps a wafer (1, 1 ') comprising a protective part (2) in a polymer gel and at least one adhesive part in a polymer gel (3a, 3b) intended to come into contact with the skin, the protective part being configured to provide mechanical protection for the area to be protected, the polymer gel forming the adhesive part having a adhesive strength greater than that forming the part protective device to ensure the maintenance of the plate on the area to be protected. The method of claim 11, comprising steps of forming the adhesive portion (3a, 3b) to from a first liquid mixture deposited on a support, (10), and formation of the protective part (2) from a second liquid mixture deposited on the medium, the first mixture and the second mixture partially mixing in an interface area (7a, 7b), before complete polymerization of the two mixtures. The method of claim 12, wherein the second mixture comprises:
about 15% polydimethylsiloxane with terminations dimethyl vinyls having a viscosity exceeding 20000 mPa.s about 25% polydimethylsiloxane with terminations dimethyl vinyls having a viscosity of between 200 and 20000 mPa.s, about 45% polydimethylsiloxane with terminations trimethyls having a viscosity of less than 100 mPa.s, about 12% fumed silica treated trimethylsiloxy, and about 3% of co-polydimethylsiloxane-polymethyl-hydrogenosiloxane with dimethyl-hydrogen terminations. The method of claim 12, wherein the second mixture comprises:
about 15% polydimethylsiloxane with terminations dimethyl vinyls having a viscosity exceeding 20000 mPa.s about 25% polydimethylsiloxane with terminations dimethyl vinyls having a viscosity of between 200 and 20000 mPa.s, about 25% polydimethylsiloxane with terminations trimethyls having a viscosity of less than 100 mPa.s, about 20% polydimethylsiloxane with terminations trimethyls having a viscosity greater than 20000 mPa.s, about 12% fumed silica treated trimethylsiloxy, and about 3% of co-polydimethylsiloxane-polymethyl-hydrogenosiloxane with dimethyl-hydrogen terminations. The method of claim 14, wherein the two liquid mixtures are deposited on a support moving (10) so as to form strips, the first mixture being deposited on the support so as to form two adhesive strips (3a, 3b) between which the second mixture is deposited to form the protective part (2) in band form. The method of claim 15, wherein the thickness and width of each of the parts protective (2) and adhesive (3a, 3b) are adjusted by a squeegee (16, 19) and lateral guides (15a, 15b). 17. Method according to one of claims 11 to 16, comprising a step of fixing on one side of the plate (1, 1 ') opposite to the face (21, 31) for come into contact with the skin of an outer layer (4, 5) non-adhesive 18. The method of claim 17, wherein the outer layer (4) is a fabric glued to the plate (1). 19. The method of claim 17, wherein the outer layer (5) is a non-adhesive polymer gel thickness between 0,2 and 0,4 mm or in a glue Silicone thickness between 0.05 and 0.4 mm. 20. Method according to one of claims 11 to 19, in which the face (21, 31) of the wafer (1, 1 ') intended to come into contact with the skin is covered a protective film (6).